By Sneha S K and Sriparna Roy
July 22 (Reuters) – U.S. FDA advisers this week will weigh whether seven popular peptides can be compounded by licensed pharmacies, but even if regulators decline to expand access, industry participants say consumer demand is likely to remain strong.
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The review comes as peptides move out of niche anti-aging clinics into the burgeoning wellness market, fueled by social media influencers, biohacking communities and endorsement from Health Secretary Robert F. Kennedy Jr.
Peptides are short chains of amino acids that proponents say can aid recovery, improve performance and support a range of health conditions. Among the peptides due for review are three called BPC-157, TB-500 and Semax, which are widely popular among fitness enthusiasts and biohackers.
The FDA’s staff reviewers had last month said there is little evidence to support the safety and effectiveness of these peptides for their intended uses and flagged a lack of adequate human clinical trials, in contrast to Kennedy’s public support.
Kennedy, who has said he used peptides with “really good effect”, has argued that restrictions on the compounds have pushed consumers toward an unregulated gray market.
The FDA’s Pharmacy Compounding Advisory Committee will meet on July 23 and 24 to consider if seven peptides should be added to the agency’s 503A Bulks List, a step that would permit state-licensed compounding pharmacies to prepare the substances for patients with prescriptions.
Any recommendation by the panel would be advisory and not binding on the agency. Several voting members have ties to businesses or clinics involved in peptide therapies, raising questions about potential conflicts of interest.
GROWING DEMAND FUELS GRAY MARKET
Despite the lack of robust data, demand for peptides has continued to grow.
Online communities on platforms such as Reddit have become hubs for peptide users, who exchange personal experiences, discuss the latest research and compare suppliers and quality-verification services.
The interest has helped fuel a gray market where consumers seek access to research-grade injections, including experimental weight-loss therapies such as retatrutide.
“Whether we agree with every current use or not, they (peptides) have become a household name, and that level of public interest is unlikely to disappear,” said Carrie Carda, national medical director at 10X Health.
The company currently offers peptide therapies and said it will comply with any regulatory changes should they arise to help patients transition care appropriately.
On Wednesday, more than 100 people plan to rally outside the FDA campus in Maryland calling on the regulator to expand access to the peptides.
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REGULATION VERSUS RESTRICTION
The FDA’s 2023 crackdown on compounded peptides curtailed access through licensed pharmacies but did little to dampen demand.
Some experts argue peptides require a different testing requirements than pharmaceutical drugs.
“The wellness sector is entirely driven by consumers, not by clinicians, and not by pharmaceutical companies,” said Jeff Cohen, a founder of the American Peptide Association.
He said many peptides are naturally occurring compounds that lack the patent protections needed to justify expensive clinical development programs.
The FDA, in documents for the meeting, said many of the peptides lack adequate human safety and efficacy data. The agency cited immunogenicity concerns, saying there was limited data on the quality, stability and consistency of the compounds.
The safest approach is a regulated system where peptides are traceable, independently tested and prescribed within a medical framework. Patients should be able to verify their origin, manufacturer, and quality, said 10X Health’s Carda.
Similarly, in a letter to the committee, the Alliance for Pharmacy Compounding urged the FDA to address safety concerns through targeted safeguards rather than outright restrictions.
The group argued that where there is a legitimate patient need, allowing peptides to be compounded by state-licensed pharmacies would provide greater oversight through prescription requirements, quality standards, inspections and adverse-event reporting.
“The 503A pathway is the first step of accountability, and I think that’s really ultimately what we’re looking for. And then we can provide patients more realistic projections for use of these things,” Michael Hall, founder of Hall Longevity Clinic in Miami Beach, who prescribes peptides to his patients.
(Reporting by Sneha S K in and Sriparna Roy in Bengaluru; Editing by Caroline Humer and Arun Koyyur)
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